Safety and Efficacy of Oral BAY85-8501 in Patients With Non-CF (Cystic Fibrosis) Bronchiectasis

Last updated: July 8, 2015
Sponsor: Bayer
Overall Status: Completed

Phase

2

Condition

Bronchiectasis

Treatment

N/A

Clinical Study ID

NCT01818544
16359
2012-004491-18
  • Ages > 18
  • All Genders

Study Summary

The primary objective of this study is to assess the safety and tolerability of 28 day oral administration of BAY85-8501 versus placebo in subjects with non-CF Bronchiectasis (BE).

The secondary objectives are to examine the effect of BAY85-8501 on pulmonary function, biomarkers of inflammation and tissue damage, and the impact on overall health and perceived well-being and to evaluate the pharmacokinetics of BAY85-8501.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Proven and documented diagnosis of non-CF (cystic fibrosis) idiopathic orpost-infectious BE (bronchiectasis) by computed tomography (CT) scan [conventionalhigh resolution CT is considered the standard], including 2 or more lobes and dilatedairways compatible with BE at initial diagnosis

  • Stable pulmonary status as indicated by the forced, expired volume in 1 second (FEV1)percent predicted ≥30% and <90% (post-bronchodilator)

  • Stable (i.e., no dose change) regimen of standard BE treatment administered at leastfor 4 weeks prior to screening

  • Cough on most days

Exclusion

Exclusion Criteria:

  • Forced, expired volume in 1 second <30% or ≥90% predicted (post-bronchodilator)

  • Recent significant hemoptysis (≥300 mL or requiring blood transfusion) in thepreceding 4 weeks before screening (and during the screening period)

  • Known cystic fibrosis and/or documented chronic bronchial asthma

  • Active allergic bronchopulmonary aspergillosis (ABPA)

  • Diagnosis of common variable immunodeficiency (CVID)

  • Systemic or inhaled antibiotic treatment within 4 weeks prior to screening

  • Treatment of an exacerbation within 4 weeks prior to screening

  • Systemic corticosteroids at >10 mg/day prednisolone equivalent for >2 weeks within 4weeks prior to screening

Study Design

Total Participants: 94
Study Start date:
April 01, 2013
Estimated Completion Date:
June 30, 2014

Connect with a study center

  • Nice, 06000
    France

    Site Not Available

  • Perpignan, 66025
    France

    Site Not Available

  • Donaustauf, Bayern 93093
    Germany

    Site Not Available

  • Rüdersdorf, Brandenburg 15562
    Germany

    Site Not Available

  • Hannover, Niedersachsen 30167
    Germany

    Site Not Available

  • Leipzig, Sachsen 04103
    Germany

    Site Not Available

  • Großhansdorf, Schleswig-Holstein 22927
    Germany

    Site Not Available

  • Kiel, Schleswig-Holstein 24105
    Germany

    Site Not Available

  • Lübeck, Schleswig-Holstein 23538
    Germany

    Site Not Available

  • Jena, Thüringen 07740
    Germany

    Site Not Available

  • Hamburg, 20354
    Germany

    Site Not Available

  • Orbassano, Torino 10043
    Italy

    Site Not Available

  • Genova, 16132
    Italy

    Site Not Available

  • Milano, 20142
    Italy

    Site Not Available

  • Napoli, 80131
    Italy

    Site Not Available

  • Padova, 35128
    Italy

    Site Not Available

  • Siena, 53100
    Italy

    Site Not Available

  • Badalona, Barcelona 08916
    Spain

    Site Not Available

  • Salt, Girona 17190
    Spain

    Site Not Available

  • Majadahonda, Madrid 28222
    Spain

    Site Not Available

  • Madrid, 28046
    Spain

    Site Not Available

  • Southampton, Hampshire SO16 6YD
    United Kingdom

    Site Not Available

  • Cottingham, Humberside HU16 5JQ
    United Kingdom

    Site Not Available

  • Leicester, Leicestershire LE3 9QP
    United Kingdom

    Site Not Available

  • Liverpool, Merseyside L9 7JU
    United Kingdom

    Site Not Available

  • Sheffield, South Yorkshire S5 7AU
    United Kingdom

    Site Not Available

  • Dundee, Tayside DD2 1UB
    United Kingdom

    Site Not Available

  • Newcastle Upon Tyne, Tyne and Wear NE7 7DN
    United Kingdom

    Site Not Available

  • South Shields, Tyne and Wear NE34 0PL
    United Kingdom

    Site Not Available

  • Wolverhampton, West Midlands WV10 0QP
    United Kingdom

    Site Not Available

  • Bradford, West Yorkshire BD9 6RJ
    United Kingdom

    Site Not Available

  • Glasgow, G42 9TY
    United Kingdom

    Site Not Available

  • London, EC1M 6BQ
    United Kingdom

    Site Not Available

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